AEGiS-UPI: FDA approves new HIV, hepatitis screen United Press InternationalImportant note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
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FDA approves new HIV, hepatitis screen

United Press International -- Dec. 30, 2008


PLEASANTON, Calif., Dec. 30 (UPI) -- The U.S. government Tuesday approved a nucleic acid test that screens for less common forms of HIV that recently have appeared in the United States.

The U.S. Food & Drug Administration approved the test from the Swiss firm Roche Diagnostics to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and hepatitis B DNA.

The test, called the cobas TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative test for human plasma. The test, which is not intended for use as an aid in diagnosis, is designed to further increase the safety of blood supplies by identifying infections earlier than traditional serology tests -- identification of antibodies in the blood, statement from the drug company said.

"Roche is committed to meeting the needs of blood centers with tests and systems that ensure the highest blood safety," Daniel O'Day, head of Roche Molecular Diagnostics, the business area of Roche Diagnostics that developed the test, said in a statement.

"Our multiplex test has been widely adopted and has demonstrated excellent performance in blood centers worldwide."
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